FDA Sends Warning Letter to Maker of Necco Wafers and Sweethearts

The FDA has sent a warning letter to the maker of Necco Wafers and Sweethearts about the conditions in their facility. The letter was sent to the New England Confectionary Company in Massachusetts. The inspection conducted late last year found “serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.”

The violations included “significant evidence of rodent activity and insanitary conditions” throughout the facility. That means the candy products are adulterated.

FDA inspectors found evidence of rodent activity in the food storage areas of the facility. Rodent excreta pellets that were too numerous to count and evidence of widespread rodent activity were found in “multiple areas” throughout the plant, on raw material, and components of the ready-to-eat products. Rodent pellets were found on the floor across from the Sweethearts staging area, the floor of the Sweethearts rolling room, the floor of the peanut roasting room, in multiple locations on the floor of the finished product storage warehouse, the floor and storage racks of the second floor maintenance area, and in multiple areas on the floor of the molding room and the loading dock. Spilled sugar and almonds were on the floor, and ripped bags of sugar and ripped bags of almonds that appeared to have been re-sealed were also observed.

Rodent pellets were also observed on trays used to make corn starch molds, trays of corn flour, a pallet of chocolate gems, racking in the raw material storage warehouse, and on the top of a pallet used to store Sweethearts. In addition, rodent urine stains were observed in multiple areas of the finished product storage warehouse and in the raw material storage warehouse.

More rodent activity was found, including gnaw holes and nesting material, in a pallet that contained cases of chocolate dipped peanuts, and on a bag of corn flour. And a dead rodent about 12″ long was observed in the parking lot south of the employee entrance.

In one of the firm’s responses, there was mention of active rodent infestation with regular trapping of live mice. Exterminator reports assessed the situation stating, “There is a significant amount of mice activity in the building.”

And the company did not maintain buildings, fixtures, and other facilities in a clean and sanitary condition, according to the letter. An unknown liquid dripping from a ventilation duct into the Sweethearts mixing room was apparently observed. Standing liquid was observed in the finished product storage warehouse and in the shipping/receiving area. Equipment was not cleaned and sanitized, since inspectors observed food residue on the ribbon blender.

The company has 15 days to respond to the letter. If re-inspection is necessary, the FDA may assess fees to cover the costs.